For patients newly diagnosed with ulcerative colitis and receiving their first systemic corticosteroids, their endoscopic response to treatment is a better predictor of future clinical course than is their clinical response, Dr. Sandro Ardizzone and his colleagues reported in the June issue of Clinical Gastroenterology and Hepatology.
In a study of 157 such patients, those who improved clinically but did not show a complete endoscopic response after 3 months of therapy had a much higher rate of negative outcomes (49%) during the ensuing 5 years than did patients who initially showed both clinical improvement and a complete endoscopic response (27%).
For this reason, clinical assessment of treatment response may not be sufficient for many patients. Instead, the degree of mucosal healing seen on endoscopy should be used to predict outcomes such as the patient’s needs for hospitalization, immunosuppressants, and even colectomy in the near future, said Dr. Ardizzone, head of the inflammatory bowel disease unit and chair of gastroenterology at "L. Sacco" University Hospital, Milan, and his associates.
Few studies have evaluated the role of mucosal healing in relation to long-term disease outcomes, and some of the studies were poorly designed in that they had heterogeneous patient populations, treatments, and durations of follow-up. Dr. Ardizzone and his colleagues performed a chart review of 157 patients seen at their hospital, a tertiary-care IBD center, between 1981 and 2006 (Clin. Gastroenterol. Hepatol. 2011 June [doi:10.1016/j.cgh.2010.12.028]).
All the study subjects had newly diagnosed moderate to severe ulcerative colitis and presented as emergencies, needing their first systemic corticosteroid treatment. They were given either oral prednisone or parenteral methylprednisolone, which was tapered over a standard period of 3 months.
A total of 68% of the subjects were men, and 12% had a family history of IBD. The median age was 34 years (range, 23-48 years). All the patients were assessed at 3 and 6 months, then at 6-month intervals for up to 5 years, or until they underwent colectomy.
Within 1 year, 65% of patients had at least one relapse, 30% required hospitalization for ulcerative colitis, 19% required immunosuppressants, and 5% required colectomy.
Within 5 years, 92% relapsed, including 38% with multiple systemic relapses. In addition, 73% required at least one new course of systemic corticosteroids; 45% required hospitalization; 28% required immunosuppressants; and 12% required colectomy.
A total of 63% of patients achieved clinical remission at 3 months, which was defined as a score of 0-1 on a modified Powell-Tuck index of clinical signs and symptoms. However, less than half of them – 38% of the entire study population – achieved endoscopic remission at 3 months, which was defined as a score of 0 on a modified Baron scale of erythema, edema, granularity, bleeding in response to touch, spontaneous bleeding, erosion, or ulceration of the gastrointestinal mucosa.
Early (3-month) treatment response on endoscopy was the only factor that correlated with the primary combined end point of need for immunosuppressants, hospitalization, and colectomy. Failure to achieve complete remission on endoscopy after the first course of steroids predicted a more aggressive course of disease.
"Our data clearly show that despite clinical improvement, endoscopic nonresponders have a significantly higher rate of combined negative end points (49%) than complete responders (27%)," the researchers said.
This suggests that physicians might want to consider ordering routine endoscopic monitoring after the initial course of corticosteroid therapy.
The study findings further suggest that in patients who do not achieve complete endoscopic healing at that time, the early introduction of more aggressive treatments, such as immunosuppressants, may be warranted. However, "this approach requires validation in prospective trials," the investigators noted.
Dr. Ardizzone and his associates are now conducting a randomized, controlled trial to determine whether such monitoring and intervention improve patient outcomes.
One of Dr. Ardizzone’s associates was supported by Fondazione Romeo ed Enrica Invernizzi. No other conflicts of interest were reported.